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NCT Number: NCT06664320

Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery

The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Patients undergoing cardiac surgery employing moderate hypothermic CPB are randomly allocated into one of two groups: in Group-ANH, ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied. After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. As a primary outcome, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konkuk University Medical Center, Seoul, South Korea

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About this study

Background: The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB are randomly allocated into one of two groups: in Group-ANH(n=29), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH (n=29)is not applied. Intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning from CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH). As a primary outcome, the inter-group difference between maximal clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control. As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, and s-Cr are determined Intergroup differences of data at T2 are performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent

Exclusion criteria

  • preoperative renal failure requiring reran replacement therapy
  • preoperative liver disease
  • preoperative low cardiac output (EF < 50%)
  • Preoperative IABP application, Atrial fibrillation, Pacemaker
  • contraindication for applying TEE
  • intraoperative withdrawal

Treatment and study plan

Acute normovolemic hemodilution (ANH)

Procedure

applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass

hydroxyethyl starch (HES 130/0.6)

Drug

hydroxyethyl starch (HES 130/0.6)

Primary outcomes

  1. Maximal clot firmness of EXTEM

    Time frame: 10 min after completion of acute normovolemic hemodilution (ANH)

    Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry

Secondary outcomes

  1. Clot formation time of EXTEM

    Time frame: 10 min after completion of acute normovolemic hemodilution

    Clot formation time of EXTEM of rotational thromboleastometry

  2. A10 of FIBTEM

    Time frame: 10 min after completion of acute normovolemic hemodilution

    A10 of FIBTEM of rotational thromboelastometry

Study contacts

Contact information is provided by the study sponsor or research team.

Tae-Yop Kim, MD, PhD

CONTACT

[email protected]

+82-2-2030-5445

Wooseul Lee, Bachelor

CONTACT

[email protected]

+82-2-2030-5448

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Impact of Mild Acute Normovolemic Hemodilution on Pre-bypass Coagulation Function During Cardiac Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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